RedHill's CEO On Biopharma's 'Two Shots On Goal' For Coronavirus Drug

REDHILL BIOPHAR/S ADR RDHL, known primarily as a biopharmaceutical company focused on gastrointestinal diseases, is joining the race to develop coronavirus treatments with two pipeline drugs it believes can help treat the disease that's triggered a pandemic. 

CEO Dror Ben-Asher spoke with Benzinga about opaganib, for which the company filed an Investigational New Drug Application with the FDA in April; and RHB-107, on which RedHill is partnering with the National Institute of Allergy and Infectious Diseases in an evaluation for COVID-19. 

Benzinga: What is current stage of opaganib and RHB-107? What type of results have they shown?

Ben-Asher: RedHill has been developing opaganib primarily for oncology for the past several years and we have tested it in well over 100 patients. When coronavirus began to spread rapidly, we decided that opaganib might apply to coronavirus. The drug is anti-inflammatory, it has antiviral properties and it acts on the same issues that moderate to severe patients of coronavirus are struggling with.

Opaganib was first opened as a compassionate use program in Israel, which means physicians can treat patients in designated hospitals using opaganib outside clinical studies. Thus far, we have results from five patients. They are doing very well in terms of overall improvement, including reduction in inflammation and a decrease in oxygenation requirement.

Some patients left the hospital while others left the ICU. It's a small sample size, but we like what we are seeing.

We recently announced that RedHill signed an agreement with the National Institute of Allergy and Infectious Diseases to evaluate RHB-107 for coronavirus. It's a priority project and thus far RHB-107 has been tested in over 300 patients.

Both Opaganib and RHB-107 are novel molecules that have plenty of data. We are pursuing both of them in the fight against coronavirus. There are very few companies out there that have 'two shots on goal' for a coronavirus drug.

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Benzinga: Can you give a brief history of RedHill's relationship with FDA? What other trials has RedHill been involved in?

Ben-Asher: RedHill has been meeting with the FDA numerous times over the last 10 years. We successfully developed and brought to the market a drug Talicia with FDA approval. Talicia was designed to treat an infection, Helicobacter pylori. Over 100 million Americans are infected with Helibobacter pylori, with some parts of the world population being over 50% infected.

In addition, we are already promoting three products commercially in the USA with 100 sales representatives in North Carolina. The largest of the three is Movantik, which we acquired in the beginning of April from AstraZeneca plc AZN. 

We have also filed a new application to start a clinical study in the U.S. for opaganib as a coronavirus drug, and we expect an FDA response very soon.

Benzinga: Can the data from Israel be used in seeking opaganib approval in the U.S.?

Ben-Asher: The data in Israel is not considered clinical study data because it's compassionate use. Opaganib is used to help patients in need based on the physician's discretion. When a physician has no better alternative, they can choose to treat a patient with opaganib.

We are pursuing clinical studies in the U.S., and upon approval from the FDA, we will move forward with a controlled study. If the data is the same in the controlled study as it is in the compassionate use in Israel, then we will have a discussion with the FDA for getting it approved.

Benzinga: What would be a timeline for the drug in the U.S.?

Ben-Asher: It's too early to tell, but the magnitude and urgency of getting the first drug approved for coronavirus is very significant. Although, the FDA is mandated to ensure that drugs are safe and effective through the requires clinical studies in a controlled setting.

The treatment for coronavirus is really short; it’s only a matter of weeks. The coronavirus does not last long, [and] therefore the studies are not expected to take long. It's not expected to be difficult to recruit patients either, because the need for a new treatment is really significant.

Benzinga: How prepared is the company to scale up production of opaganib if approved in the U.S.?

Ben-Asher: RedHill has been working hard toward boosting production to a large scale. We secured a manufacturer and we can scale up manufacturing, including getting additional manufacturers, as soon as the demand for opaganib is needed.